Impact of the Systematic Introduction of Low-cost Bubble Nasal
CPAP in a Developing Country: a prospective pre- and postintervention study
Rossano Rezzonico1,4, M Letizia Caccamo2, Valeria Manfredini1, Massimo Cartabia4, Nieves
Sanchez3, Zoraida Paredes3, Patrizia Froesch5, Franco Cavalli5, and Maurizio Bonati4
Correspondence to
Maurizio Bonati; maurizio.bonati@marionegri.it
1
ABSTRACT
Objective: to test the impact of using a bubble NCPAP (bNCPAP) device as the first intervention
on in-hospital newborn mortality.
Design: Prospective pre-intervention and post-intervention study.
Setting: The largest Neonatal Intensive Care Unit (NICU) in Nicaragua.
Participants: In all, 230 (2006) and 385 (2008) patients were included.
Intervention: Starting from May 2006, a strategy was introduced to promote the systematic use of
a bNCPAP to avoid intubation and mechanical ventilation (MV) in newborns requiring ventilatory
assistance (VA). Data regarding gestation, delivery, postnatal course, mortality, length of
hospitalisation and nursing workload (hours) were collected for infants assisted between May and
December 2006, before the project began, and between May and December 2008, two years
afterwards.
Primary and secondary outcome measures: Primary end point was the pre- vs post-intervention
proportion of newborns died in-hospital. Secondary endpoints included rate of intubation, and
duration of NICU stay.
Results: Significant differences were found in the rate of intubation (72 vs 39%; p=0·0001) and the
proportion of patients exclusively treated with bNCPAP (27% vs 60·8%; p=<0·0001). Mortality
rate was significantly reduced (40·4 vs 22·7%; p=0·0001) according to lower gestational age
(p<0·0001), intubation and MV (p<0·0001).
Conclusions: This is the first extensive survey performed in a large NICU from a LMIC, proving
the efficacy of the systematic use of a bNCPAP device in reducing newborn mortality, as well as in
providing qualitative changes in nursing workload. These findings are an incentive for considering
bNCPAP as an elective strategy to treat preterm newborns with respiratory distress syndrome in
LMCIs.
2
ARTICLE SUMMARY
Article focus

In Lower-Middle Income Countries (LMICs), a majority of the under-5 mortality rate is due
to neonatal deaths. Evidence lists the Nasal Continuous Positive Airway Pressure ventilation
(NCPAP) as an effective, low-cost, and easy-to-use intervention for enhancing newborn
survival.

The objective of this study was to evaluate the effects of using a bubble NCPAP (bNCPAP)
device as the first intervention on mortality of newborns in the largest Neonatal Intensive
Care Unit (NICU) in Nicaragua.
Key messages

The early use of bNCPAP as the primary respiratory assistance strategy halved the mortality
of newborns in NICU, and positive changes in medical assistance and nursing workload
were notable.
Strengths and limitations of this study

This is the first wide scale study demonstrating the efficacy of the systematic use of a lowcost bNCPAP device in a large NICU from one of less human developed countries.
Strengths were that the study was conducted in a natural setting where the clinical research
or audit studies are not part of the activities, thus the study was also an active educational
initiative.

The main limitations were that no risk index to state the level of severity of newborns could
be applied and there was a lack of both data regarding maternal socio-economic
characteristics and a thorough analysis of the medical costs.
3
INTRODUCTION
A worldwide decrease in child mortality has been achieved in the last few years, following the
global attempt to pursue Millennium Development Goal 4 (MDG4), adopted at the UN Millennium
Summit in 2000 and targeting a 2/3 reduction in under-5 mortality by 2015. In the last decade,
however, the neonatal death rate seems to have increased from the 37% observed in 2000 to 42% of
the overall estimated child mortality recorded in 2010.1 Preterm birth and related complications are
important leading causes of neonatal mortality.
In Lower-Middle Income Countries (LMICs), newborn deaths are dramatically prevalent, and lack
of human and economical resources makes accomplishing the MDG4 challenging.2 Among the
interventions for reducing the newborn mortality rate, Nasal Continuous Positive Airway Pressure
Ventilation (NCPAP) is of proven efficacy3. The bubble NCPAP (bNCPAP), is the simplest, lowcost respiratory support, showing theoretically and experimentally advantages and the same or
greater clinical efficacy, compared to other, more sophisticated methods to deliver
NCPAP
(variable flow and ventilator NCPAP).4–6,23,36,37
After positive experiences from Scandinavian countries,8 data published by the Neonatology
Committee for the Developmental Epidemiology Network in 2000 have shown a significant inverse
relation between incidence of Bronchopulmonary Dysplasia (BPD) and use of NCPAP, as
compared with MV, in very low birth weight (VLBW) newborns.9 This was the starting point of
same important trials: SUPPORT, COIN, VON, CURPAP, Colombian Network and Neocosur
Network on early use of NCPAP, also in association with surfactant. As reviewed by W. Carlo, this
“gentle ventilation”, started soon after birth, appear to reduce the need for MV, the BDP/death and
is alternative to the prophylactic or early surfactant approach in low, very low, and extremely low
birth weight infants (ELBW).7,8,10–13, 36,37
The use of NCPAP has begun to increase and is progressively replacing conventional MV,
becoming the cornerstone treatment for newborn Respiratory Distress Syndrome (RDS).
4
The, few studies addressing NCPAP use in LMICs are interesting, and are burdened by the loss of
power due to their small numbers, but all agree that NCPAP, particularly bNCPAP, for efficacy,
cost effectiveness, and ease of use, should be the primary assistance technique employed in
newborns with RDS.3,14–16,25,26,33,37
Nicaragua is the second poorest country in Central America and in 2009 the under-5 child mortality
was 27/1000 newborns (8/1000 in the USA), with a maternal mortality of 100/100,000 live births.
Among all causes of under-5 mortality, in 2008, 45% was due to neonatal causes, of which 22%
were related to prematurity, 13% to congenital anomalies, 8% to asphyxia, and 2% to sepsis.18,19
The Bertha Calderon Hospital (BCH) is the biggest maternity hospital in Nicaragua, accounting for
more than 10.000 deliveries and 600 admissions in the neonatal intensive care unit (NICU) per year.
AMCA (Aiuto Medico Centro America) is a Swiss non-governmental organisation operating since
198521 in Central America, particularly Nicaragua and El Salvador. From 2005 to 2007 it set up,
with the local NICU staff, a progressive programme, starting with the newborn resuscitation
training courses, based on international guidelines,22 pain and O2 therapy-related risks control,
reduction number of newborns on MV through the use of the bNCPAP device,.
METHODS
AIM OF THE STUDY
A prospective study was thus performed to determine the impact of the early use of low cost
bNCPAP to reduce intubation and MV and to determine its effects on mortality rate and duration of
NICU stay, in the largest NICU in Nicaragua,
The study obtained authorisation by the BCH director.( credo che questa parte vada ampliata )
5
Study Population and Data Collection
Data on all newborns admitted to the BCH NICU with a history of ventilation assistance (VA) and
without (NAV) between May 1 and December 31, 2006 (before the project began), and from May 1
to December 31, 2008 (two years after the project began), were anonymously collected from the
medical records by a doctor kept blind to the study purposes.
VA patients, the study population, were divided into groups: 1) those receiving only MV; 2) only
bNCPAP; 3) bNCPAP first, than MV (bNCPAP-MV); and 4) MV first, than bNCPAP (MVbNCPAP). The groups of patients requiring MV alone or with bNCPAP (MV, bNCPAP-MV, MVbNCPAP) were categorised into an additional group called endotracheal tube (ETT). (Figure 1)
Exclusion criteria were: birth malformations, transfer to another hospital, suboptimal patient
assistance due to lack of devices, parents consent to ventilation, data on hospitalisation, ventilation
mode or outcome.
All patient information was collected and included delivery mode (vaginal=VAG or caesarean
section=CS), gender (M/F), gestational age (GA) and birth weight (BW), main diagnosis at
recovery, mean duration of NICU stay, recovery outcome, prenatal steroids, APGAR index,
resuscitation measures, surfactant use, and age at start, and duration of respiratory assistance
(hours).
Resuscitation measures and ventilation assistance choice
During both 2006 and 2008, delivery room local medical staff provided resuscitation and ventilation
assistance. Newborn resuscitation was classified as non-advanced (naRES) when it only included
airway clearance, tactile stimulations, free-flow oxygen delivery, and/or bag and mask positive
6
pressure ventilation. Advanced resuscitation (aRES) included all naRES manoeuvres plus chest
compressions, intubation, or drug administration.22
No protocols or severity score (eg. CRIB II) were defined during the study period due to lack of
medical devices such as pulse oxymeters, blood gases analyser, and radiographic equipment in the
delivery room.24 The decision to start or to continue ventilation assistance with MV or bNCPAP
was based on clinical and anamnestic criteria.
No substantial changes in delivery room assistance, medical or nursing staff were made during the
study period.
INTERVENTION
NCPAP Device
bNCPAP ranks as a highly sophisticated, fluid-dynamic system in which the bubbles produced by
the expiratory water valve improve lung mechanical characteristics and minimise the respiratory
system impedance.10,23,35
bNCPAP kits were provided to the NICU and included a humidifier and re-sterilisable breathing
circuits (Fisher & Paykel, New Zealand) and to minimise infection risks, disposable nasal cannula
(Hudson, USA). To further reduce costs, , a dual Air/Oxygen flowmeter (Harol, Italy) were chosen
as the blender, because much less expensive than automatic blenders, with no influence on quality
In 2007, AMCA experts provided BCH staff with an extensive course on bNCPAP use, that were
repeated thereafter by locally particularly trained staff.
7
Statistical analysis
Microsoft Office and SAS system software, release 8·02, were used for analysis.
BW and GA of the newborns included were compared between the two years considering three
populations: NICU admitted patients, VA patients who survived, and VA patients who died. The
comparison was first made using the normality of distributions through the indices of asymmetry
and kurtosis. The Student's t-test was then used to define the equality of means with an α-level of
0·05. In cases in which the preliminary F-test led to the rejection of the null hypothesis of equality
of variances, the Satterwaite method was used for the comparison of averages.
Quantitative variables were grouped into classes and transformed into qualitative variables in order
to compare the groups of patients from 2006 and 2008 and to define the significance of the
differences observed through the chi-square test, using an α-level of 0·05.
Finally, a logistic regression model was built to evaluate the death-risk determinants in VA patients.
Through a stepwise selection method, it was possible to include in the model only those variables
that were significant at an α-level of 0·1.
RESULTS
During the periods analysed, 850 newborns were admitted to the NICU (341 in 2006 and 509 in
2008). In all, 33 cases (9·7%) from 2006 and 38 (7·4%) from 2008 (p 0·253) did not fit inclusion
criteria. leaving 779 cases (308 and 471, respectively).. Of these, 613 were the the VA newborns
(2006 n=230, 74·7%; 2008 n=383, 81·1%) and belong to the ventilation group as reported in
Figure 2.
8
VA newborn characteristics
The patient characteristics, described in Table 1, were all comparable except for a greater
proportion of CS deliveries and of VLBW patients during 2008 (p=0·0001 and 0·0371,
respectively). No patients received surfactant treatment. The 1st and 5th minute APGAR indices were
comparable in naRES and aRES newborns from both groups Furthermore, a higher proportion of
patients required any level of birth resuscitation in 2006 (p=0·0006), and, among these, a higher
proportion required aRES (p=0·013). No differences were observed in rate of steroid prophylaxis
(66·4% in 2006 and 68·4% in 2008).
NICU admission diagnoses, despite aforementioned limitations, were comparable in 2006 and 2008.
(Appendix Table 1a)
Ventilation assistance mode
In 2006 the MV patients prevalence were 50% and decreased to 10% in 2008 (p=0·0001). During
the two periods, no differences were found in the proportion of MV-bNCPAP patients (p=0·5467),
while a significant increasing from 15.2% to 23% (p=0·02) in the bNCPAP-MV group, The rate of
ETT patients was 72% in 2006 and decreased to 39% in 2008 (p=0·0001).
The introduction of bNCPAP led to an increase newborns, treated with this device, from 27·8% in
2006 to 60·8% in 2008 (p <0·0001), consistent with the decrease in ETT patients. (Figure 2)
In 2008, 61·8% of the bNCPAP newborns started treatment at birth, 85% within the 1 st, and 97%
within the 2nd, hour of life.
Mortality
In 2008 the number of VA patients admitted to the NICU increased to 63%, but mortality decreased
significantly from 40·4% (n=93) in 2006 to 22·7% (n=87) (p<0·0001). In ETT newborns, mortality
rate remained unchanged, from 50·3% to 53·33% (p=ns). (Figure 3) If only the MV patient group is
9
considered,
however,
mortality
increased
from
52·8%
in
2006
to
90%
in
2008
(p<0·0001).(Appendix Table 2a)
In the bNCPAP group deaths decreased from 7·8% in 2006 to 3·0% in 2008, but the small number
of cases does not permit statistical analyses.
In VA newborns who died in 2008, however, significant lower mean GA (30·7 vs 32·5 weeks) and
BW (1,383 g vs 1,633 g) were observed compared to 2006. (Appendix Table 2a)
Finally, during the two periods analysed, the logistical regression model applied to the mortalityrelated risk factors revealed two important inverse relations: probability of death and GA
(p<0·0001), and probability of death and ETT (p<0·0001). (Table 2)
NICU duration of stay and ventilation mode distribution
Overall NICU length of admission remained unchanged between 2006 and 2008. An increase was
observed, however, in VA patients: 14·7 days in 2006 and 17·5 days in 2008 (p=0·048).
In MV patients, NICU stay decreased from 14·4 days in 2006 to 5·7 in 2008 (p=0·0017), although
the limited population size of this group had no positive influence on overall duration of NICU stay
of VA patients. (Table 3)
In all VA groups, the means hours of the two types of assistance (MV and bNCPAP) were
calculated separately, including those receiving bNCPAP-MV and MV-bNCPAP,. As shows in
Table 3 values , were all comparable during the two periods.
. The overall number hours MV and bNCPAP were calculated in the two study periods, showing a
209,6 % increase in the overall bNCPAP hours in 2008 compared to 2006, due to the increase in
bNCPAP newborns. (Table 3)
10
DISCUSSION
In this study the interventions proposed resulted in a decrease in the rate of intubation
and
mechanically ventilated newborns (72 vs 39%; p=0·0001) and a proportional number of patients
exclusively treated with bNCPAP (27% vs 60·8%; p=<0·0001). Mortality rate was significantly
reduced (40·4 vs 22·7%; p=0·0001) according to lower gestational age (p<0·0001) and MV
(p<0·0001) in the two periods analysed. The mean of length of NICU stay increase in VA patients
in 2008 of a mean of 2,9 days. A great increase of overall hours of hours in bNCPAP (209%) result
in 2008 compared to 2006.
Characteristics of the VA newborns
During the two periods, the characteristics of all VA patients were similar. The BCH is the national
referral centre for pathologic pregnancies. The higher 2008 CS rate may be explained by a more
general prudent attitude towards term and preterm delivery during recent years27,28 rather than by
greater severity of cases in 2008. The relatively increase of CS percentage is also likely due to the
hospital characterises Conversely, the decreased rate of newborns requiring resuscitation (53·7% in
2006 to 39·1% in 2008) may be related to the greater number of CS in 2008. It was not possible to
apply a risk index,24 however, no differences emerged between 2006 and 2008 in Apgar indexes in
resuscitated newborns, supporting comparable clinical conditions in the two groups. Consistent with
this hypothesis the multivariate analysis showed no influence of delivery mode and newborn
resuscitation on mortality.
Steroid prophylaxis against RDS was the only available prenatal care index and was comparable in
the two periods. The lack of data on other prenatal care and maternal socio-economic characteristics
(instruction, wealth, parity, age, income, etc.) may be a limit of this study. A change in prenatal care
and maternal socio-economic conditions, however, is unlikely given the short study period. During
the study, GA and MV emerged as the most relevant factors in determining the outcome of all VA
newborns. Despite the fact that no differences were found between 2006 and 2008 in terms of mean
11
GA, a greater number of VLBW was observed in 2008, which may have resulted, at least, in a more
vulnerable population.
Ventilation mode and mortality
In this study was not possible to evaluate the MV-related lung damages, such as BPD,7,9,10 but only
intubation and MV impact on mortality rate.
Multivariate analysis for the most influential death-related risk factors shows MV as one of the two
only relevant variables
In the ETT group of patients, mortality rate remained unchanged (53%), but the in the ETT group,
patients decreased from 72% in 2006 to 39% during 2008, leading to a consistent reduction in the
overall mortality. (Figure 3) In the MV patient group, the death rate increased from 59% to 90%,
with no impact on the overall mortality, due to the concurrent reduction of newborns in this group
(from 50% to 10·4%).
The more compromised newborns received MV more frequently, and this supports the higher
mortality rate observed within this subgroup in 2008.
In the groups of MV-bNCPAP patient, bNCPAP was applied after MV to stabilise patients and to
avoid re-intubation,4 and remained very small (6% of all VA newborns) during the examined
periods, with no influence on mortality.
Patients failing to respond to the bNCPAP, during both periods, have been switched to MV
(bNCPAP-MV group). Since the use of bNCPAP was systematically encouraged during 2008, a
consistent increase in failure incidence (15,2 vs 23,0 % p=0.02) in this group was conceivable,
however, the bNCPAP failure rate, in the bNCPAP-MV group, was limited and comparable with
literature data. 29,38. As shown in Appendix Table 4a the mortality rate in this group didn’t change in
the two periods. This is a clinically relevant point, since an inappropriate delay in MV is known to
compromise its efficacy and the patient’s clinical outcome.
12
These all considerations
seem to support an appropriate application of
both ventilation
methodologies, during 2008.
The high success of the non-invasive respiratory support was also related to its early
application,10,30 as 62% of the patients started at birth and 97% within the first two hours of life.
Moreover, the mean age at death among newborns during 2008 was two gestational weeks inferior
to that observed in 2006, further supporting the improvement in assistance quality level.
Duration of NICU admission and distribution of ventilation
Mean duration of NICU stay increased by 2·9 days during 2008 in newborns from the VA group.
(Table 3)
Non-respiratory impairment, infectious complications, nutritional factors, and preterm birth-related
complications concur in the complexity of the assistance and length of NICU stay.
In 2008 compared to 2006 the total hours of MV for the ETT group increase only of 7,6% ,
because, despite the increase of number of VA newborns in 2008, the ETT group decrease from
72% to 39% in 2008, resulting in nearly the same number of newborn. (Table 3). Recent data have
shown that the rate of serious adverse events related to MV (accidental disconnection from the
respiratory circuit, unintentional removal or obstruction of the tracheal tube) is proportional to the
nursing workload.31 It was hypothesized that, without the systematic introduction of the bNCPAP,
and with the same rate of ETT newborns as in 2006 (72%), in 2008, 276 newborns would have
received invasive ventilation and required approximately 31960 hours of mechanical ventilation,
which is 85% more than those actually provided. Assistance shifted to the bNCPAP patients,
accounting for a 209% increase in the overall amount of bNCPAP hours of assistance compared to
2006. In view of the increased overall admissions in 2008, a reduction in nursing workload was
improbable, however, compared with ETT cases, the need for assistance was inferior for bNCPAP
patients32 and it is indubitable that, with no reduction in ETT proportion, the potentially adverse
13
events related to MV would be increased and in particularly the nursing workload in 2008 would
have been unaffordable .
NCPAP in LMICs
Few studies evaluating NCPAP use in LMICs exist. Urs and colleagues in a prospective
observational study obtained an 80% success rate using bNCPAP in 50 Indian preterm infants (2837 weeks GA), supporting the primary use of the bNCPAP in poorer countries.33 In a retrospective
descriptive analysis,
from Zimbabwe, 234 newborns (1,730 g mean BW), with a death rate
incidence of 46·4%, were analysed to compare MV with NCPAP respiratory support. MV resulted
as the only variable associated with a significant increase in death risk, when compared to
NCPAP.15
In extreme conditions, the lack of resources leads to restrictive criteria for access to NICUs. In
South Africa, Piepier and colleagues found that, in 21 VLBW newborns who were not admitted to
the NICU, the introduction of NCPAP support led to a significant reduction in mortality rate,
without severe complications, and that, given the simplicity of the method, it could be provided by
trained nurses even in VLBW infants.14 The safety and efficacy of bNCPAP, applied by trained
nurses for reducing MV, was confirmed by Koyamaibole.26 A recent RCT Indian study comparing
bNCPAP vs ventilator NCPAP, has an higher success in managing preterm neonates with early
onset respiratory distress , with comparable safety.36
Despite the fact that surfactant was listed as an essential drug by the World Health Organisation, its
use in resource limited settings is a matter of debate34 Its cost is unaffordable for the health
economy of most developing countries, including Nicaragua and bNCPAP might is an affordable
and determinant strategy for reducing MV and the need for surfactant therapy.
Al these studies , even are burdened by the loss of statistical power due to their small numbers, but
all agree that early administration of NCPAP, particularly bNCPAP, for efficacy, cost effectiveness,
14
and ease of use, should be the primary assistance technique employed in newborns with RDS in
LMICs. 3,14–16,25,26,33,34,36,37
CONCLUSIONS
This is the first study in a large NICU from a developing country demonstrating an association
between the systematic use of a low-cost bNCPAP device and the reduced mortality and strongly
supports the early use of bNCPAP as the primary respiratory assistance strategy.
The proportion of bNCPAP newborns reached 60·8% and mortality decreased to 22·1% in 2008,
with no significant differences in the analysed populations. Furthermore, the positive changes in
medical assistance and nursing workload were notable. Economic data were missing, although, as
do other LMICs with restricted health resources and high neonatal mortality rate, Nicaragua has
limited NICU facilities and adequate strategies are needed to avoid invasive procedures in order to
contain the need for sophisticated technologies and qualified medical staff and to reduce economic
pressure.
Author affiliations
1
NICU Rho Az. Ospedaliera “G. Salvini” Garbagnate Milanese, Italy
2
Az. Ospedaliera Universitaria L. Meyer, Florence, Italy
3
UCIN Hospital Bertha Calderon Managua, Nicaragua
4
Department of Public Health, Laboratory for Mother and Child Health, IRCCS – Istituto di
Ricerche Farmacologiche Mario Negri, Milan, Italy
5
AMCA, Aiuto Medico Centro America, Giubiasco, Switzerland
Acknowledgements The authors acknowledge the Bertha Calderon NICU nurse and medical staffs
for the incredible daily clinical work in “not easy” conditions. We thank Nicolette Gianella and
15
Manuela Cattaneo for coordinating the project in Nicaragua and in Switzerland. Chiara Pandolfini,
Rita Campi, Filomena Fortinguerra, Antonio Clavenna from the Department of Public Health of the
Mario Negri Institute gave support to the authors.
Contributors RR and LC conceived the study, wrote the study protocol and trained the medical
staff in the Bertha Calderon Hospital. RR with MB wrote the first draft of the manuscript. NS
supervised clinical work in Managua and SP collected data in the Bertha Calderon Hospital. MC did
the statistical analyses. VM gave an important contribution to writing the paper. MB defined and
supervised the analyses. PF and FC, as past president of AMCA, coordinated the contacts between
Switzerland and Nicaragua. All investigators reviewed and contributed to the manuscript.
Funding The study was funded by a private donation collected by AMCA a non-profit Swiss
association for international cooperation and development.
Competing interests None
Ethics approval Institutional Review Board of the IRCCS – Istituto di Ricerche Farmacologiche
Mario Negri, Milan, Italy
Data sharing statement Access to the study data may be provided by the authors to other
researchers upon request.
16
17
Table 1. Characteristics of the newborns with ventilatory assistance (VA)
2006
VA patients
2008
230 (74·7)
p
383 (81·3)
F/M
88 /142
(62)
145/238
(61)
ns
CS/VAG
121 /109
(111)
261 /119
(219)
<·0001
Prenatal Steroids
144/73
(66·4)
257/119
(68·4)
ns
216
8
73
70
63
2
34·3
[3·93]
379
18
112
135
114
0
34·4
[3·79]
ns
ns
ns
ns
ns
n.a.
217
14
58
87
58
1975
[792]
377
38
73
161
105
2001
[766]
ns
ns
0·0371
ns
ns
(39·1)
(18·9)
117
0·0006
ns
GE Χ , weeks
<27
28-33
34-36
37-42
>42
BW g
ELBW
VLBW
LBW
NBW
Χ
RES Tot/VA
aRES/naRES
Apgar 1’ naRES
5’ naRES
116 /216
38 /78
6·28 [1·6 ]
8·22
[1·2 ]
(53·7)
(32·8)
78
78
147/376
28 /117
[1·5
6·23
8·00
[1·1 ]
117
ns
27
ns
Apgar 1’ aRES
2·68
[2·0 ]
38
2·15
[1·5]
5’ aRES
4·32
[2·5 ]
38
3·89
[2·3]
3·2 [2·1]
29
2·3 [1·5]
21
Apgar 1’ Intubated
27
ns
ns
X mean (%); [SD]
RES newborns resuscitated at birth
naRES: non-advanced resuscitation (clear airways, tactile stimulations, free-flow oxygen delivery and/or bag and mask
positive pressure ventilation)
aRES: advanced resuscitation (including all naRES manoeuvres and/or chest compressions and/or intubation and/or
drug administrations)
18
Table 2. Logistic regression model for death risk and variables considered
Odds ratio
Year 2008 vs 2006
BW
GA
CS vs VAG
Gender F vs M
Prenatal Steroid (yes vs no)
RES (no vs yes)
bNCPAP vs EET
BW
CS
VAG
GA
RES
95% Confidence Interval
0·647
1·000
0·796
1·064
1·216
0·909
0·671
0·045
0·394
0·999
0·711
0·649
0·743
0·550
0·414
0·023
p-value
1,062
1·000
0·891
1·744
1·988
1·592
1·088
0·090
ns
ns
<0·0001
ns
ns
ns
ns
<0·0001
0,809
<0·0001
birth weight
caesarean section delivery
vaginal delivery
gestational age
newborns resuscitated at birth
Con STEP WISE
GA
0,757
0,708
bNCPAP vs ETT
0,041
0,021
19
0,080
<0·0001
Table 3. Distribution of NICU stay and duration of ventilation
2006
2008
p
Mean
[SD]
N
Mean
[SD]
n
VA patients
VA patients, survived
14·6
20·4
[16·2]
[17·7]
218
125
17·5
20·7
[19·9]
[21·1]
376
289
0·048
ns
MV group
11·7
[14·8]
108
5·7
[7·4]
39
0·0017
MV-NCPAP group
bNCPAP-MV group
EET group
22·7 [15·1]
18·8 [ 21·4]
14·4 [16·9]
16
35
159
31·5 [25·4]
21·1 [ 23·4]
18·6 [22·3]
22
87
148
ns
ns
ns
bNCPAP group
15·1
[14·6]
59
16·9
[18·2]
228
ns
94·4
138·1
107·0
101,6
[98·6]
[113·1]
[150·9]
[113·6]
107
16
35
158
90·9 [139·1]
136·5 [100·4]
121·8 [103·7]
115,9 [113·9]
39
22
88
149
ns
ns
ns
ns
bNCPAP group
MV-bNCPAP group
bNCPAP-MV group
48·4
55·5
49·5
[52·0]
[31·3]
[43·9]
59
16
35
42·2 [47·4]
68·8 [75·5]
68·1 [105·3]
229
21
86
ns
ns
ns
All bNCPAP groups,
49·8
[46·7]
110
50·5
336
Ns
Total hours of MV
16051
158
17265
Days in NICU
Hours of MV
MV group
MV-bNCPAP group
bNCPAP- MV group
EET group,
Hours of bNCPAP
% increase 2008/2006
Total Hours of bNCPAP
% increase 2008/2006
[69·5]
149
7,6
5477
110
[SD]
20
16958
209,6
336
Figure 1. Flowchart showing patient distribution
NICU admitted
Ventilatory Assisted
newborns (VA)
Intubated and
ventilated newborns
(ETT)
Mechanically Ventilated
only newborns (MV)
Non Ventilatory Assisted
newborns (NVA)
Bubble-CPAP only
newborns (bNCPAP)
Mechanically Ventilated
newborns plus bNCPAP
(MV-bNCPAP)
21
bNCPAP plus Mechanically
Ventilated newborns
(bNCPAP-MV)
Figure 2. Ventilatory assisted newborns and ventilation type
22
Figure 3. Distribution by ventilation type and related deaths (striped)
23
24
APPENDIX
Table 1a. Comparison of recovery diagnoses
Diagnoses
2006
2008
2006 (%)
2008 (%)
Unknown
Apnea
Asphyxia
Seizure
RDS
Sepsis and Shock
Polycytemia
6
8
13
2
185
15
1
10
14
19
3
311
26
0
2·6
3·5
5·7
0·9
80·4
6·7
0·4
2·6
3·7
5·0
0·8
81·1
6·8
0
Total
230
383
100·2
100
RDS includes: pulmonary bleeding, congenital pneumonia, prematurity RDS, MAS, transient neonatal tachypnoea,
pulmonary emphysema
25
Table 2a. Mortality rate distribution
2006
2008
P
Deaths in NICU
96/308
(31·2)
93/471
(19·8)
0·0003
3/78
(3·8)
6/88
(6·8)
n.a.
93/230
(40·4)
87/383
(22·7)
<0·0001
Deaths ETT
88/166
Deaths MV
60/115
Deaths MV-NCPAP 7/16
Deaths NCPAP-MV 21/35
(53·0)
( 52·2)
(43·7)
(60·0)
80/150
36/40
1/22
43/88
(53·3)
(90·0)
(4·5)
(43·9)
0·950
<0·0001
n.a.
0·2647
(7·8)
7/233
(3·0)
n.a.
(n 87)
(n 87)
30·7 [4·1]
1383[656·6]
0·0043
0·020
Deaths NVA
Deaths VA
Deaths NCPAP
GE Χ deaths VA
BW Χ deaths VA
5/64
(n 91)
(n 92)
32·5
[4·2]
1633 [774·8]
(%) ; [SD]
26
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